BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 5235411 · Received November 19, 2015

    Report

    Report Number
    3001845648-2015-00244
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    July 1, 2014
    Report Date
    October 27, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    PMA / PMN Number
    P100022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P100022/S001. FDA MDR REPORT REQUIRED BASED ON THE SURGICAL INTERVENTIONS [BYPASS AND POBA] CARRIED OUT AND THE SUBSEQUENT PERMANENT IMPAIRMENT OF THE PATIENT [AMPUTATION OF LEFT LOWER LIMB ] FOLLOWING THE RESTENOSIS OF THE LIMB WHERE A ZILVER PTX STENT WAS INDWELLING. THE ZIV6-35-125-6.0-120-PTX STENT OF LOT NUMBER C791324 WAS IMPLANTED IN THE PATIENT THEREFORE IS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. IT WAS CONFIRMED THAT IMAGES WOULD NOT BE AVAILABLE TO SUPPORT THE COMPLAINT INVESTIGATION AND NO OTHER INFORMATION COULD BE PROVIDED. IT CAN BE NOTED STENOSIS OF THE LOWER LIMB FOLLOWED BY OCCLUSION OF THE BY-PASS, MAY SUGGEST PROGRESSING ARTERY DISEASE. THIS CAN BE ASSOCIATED WITH THE RESTENOSIS PROCESS. HOWEVER, A DEFINITIVE CAUSE OF THIS EVENT CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR; THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. IT CAN BE NOTED THAT BYPASS, AMPUTATION OF FOOT AND RESTENOSIS OF THE STENTED ARTERY ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH PLACEMENT OF THIS DEVICE. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. NO INFORMATION REGARDING PATIENT OUTCOME WAS PROVIDED. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(6) 2012 THE ZILVER PTX STENT WAS PLACED IN LEFT SFA OF THE PATIENT. (B)(6) 2013 BY-PASS PROCEDURE WAS PERFORMED AS THE LEFT LOWER LIMB STENOSED 100%. (B)(6) 2014 AS BY-PASS MADE ON (B)(6) 2013 GOT OCCLUDED, POBA WAS PERFORMED. (B)(6) 2014 AMPUTATION OF THE LOWER LIMB WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767803 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR